President Trump's Operation Warp Speed initiative aims to have a COVID-19 vaccine available by the end of the year; Slaoui, who helped get the first cervical cancer vaccine to market and win European approval of the first malaria vaccine while at GlaxoSmithKline, is tasked with coordinating the government's contributions to coronavirus vaccine effort and achieving what would be twin scientific and manufacturing miracles.
Moncef Slaoui, former chairman of global vaccines at GlaxoSmithKline PLC, has been given the task of leading President Trump's Operation Warp Speed initiative, with the goal of producing a COVID-19 vaccine by the end of the year.
He is credited with overseeing the development of several vaccines during his 29-year career at GSK, including the cervical cancer...
Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
US FDA’s 2015 accelerated approval called for confirmatory trial completion by 2018, but study initiation was delayed. Completed in 2022, the trial not only verified Bexsero’s clinical benefit, it also served as the pivotal study for GSK’s pentavalent meningococcal vaccine candidate.
To help sponsors developing candidate mpox vaccines, the World Health Organization will soon be finalizing guidance on the preferred and minimum characteristics these products must satisfy regarding efficacy, dose regimen and other aspects to secure regulatory approval.
The WHO’s emergency committee has warned of a lack of understanding of the epidemiology of mpox, the limited availability of vaccines, and the complexities of donations and procurement.
Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
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